NCCAM Omega-3 Fatty Acids Study To Commence In April
This article was originally published in The Tan Sheet
Executive Summary
The National Institutes of Health is sponsoring several clinical trials on omega-3 fatty acids, including one investigating their effect on major depression and bipolar disorder and another studying fatty acids' antiarrhythmic effects.
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The National Institutes of Health is sponsoring several clinical trials on omega-3 fatty acids, including one investigating their effect on major depression and bipolar disorder and another studying fatty acids' antiarrhythmic effects. The National Center for Complementary & Alternative Medicine is providing the funding for the $1.9 mil., four-year depression/bipolar disorder trial, with the National Institute of Mental Health participating as a co-sponsor. The investigator-initiated study will be led by Andrew Stoll, MD, McLean Hospital, Harvard University, and is expected to begin in April. The trial initially will involve about 120 subjects, who will receive either 6 g of omega-3 fatty acids or placebo daily for 16 weeks. The omega-3 fatty acids are being supplied by the Washington, D.C.-based Omega-3 Research Institute, which collects fatty acids from various industry sources to remove potential bias toward a particular manufacturer. Study subjects will be allowed to continue taking any previous medications. After two weeks, heart rate, temperature and blood pressure will be checked, and mood changes and side effects will be evaluated. The therapy's effectiveness will be measured using the Clinical Global Impression Scale, Hamilton Depression Rating Scale, Young Mania Rating Scale and Global Assessment of Function Scale. Upon conclusion of the 16-week period, all patients will be allowed to continue in the study for an additional 8 months, with all participants receiving omega-3 fatty acids. Patient evaluations will occur once a month and blood will be drawn at the last visit to measure the subjects' fatty acid plasma concentration. Several studies without NIH funding also are investigating the effects of omega-3 fatty acids on various mental health states. A multicenter, multinational trial funded by the Bethesda, Md.-based Stanley Foundation showed those taking 2 g or 4 g of eicosapentaenoic acid (EPA) reduced schizophrenic symptoms by 22%, as measured on the Positive and Negative Schizophrenia Symptom Scale. Other ongoing efforts include a Martek Biosciences-funded study at Baylor University investigating the effects of docosahexaenoic acid (DHA) on major depression, and a trial at the University of Cincinnati examining EPA and major depression. NIMH, along with NCCAM and NIH's Office of Dietary Supplements, also is funding a study looking at St. John's wort's efficacy in treating depression (1 (Also see "NIMH St. John's wort trial, using Lichtwer Pharma product, to begin in October." - Pink Sheet, 15 Jun, 1998.)). If the omega-3 fatty acid studies result in positive findings, the research could lead to additional structure/function claims for dietary supplements containing fatty acids or be used to support a health claim for the nutrients. Under the Pearson v. Shalala court decision, FDA is reconsidering a health claim linking consumption of omega-3 fatty acids with a reduced risk of coronary heart disease. In Nov. 21 comments to the agency, the Council for Responsible Nutrition, Consumer Healthcare Products Association and National Fisheries Institute recommended a qualified claim on the substance/disease relationship (2 (Also see "Qualified Omega-3 Fatty Acid Health Claim Proposed By Industry Group" - Pink Sheet, 29 Nov, 1999.)). Other studies of the nutrient include two funded by the National Heart, Lung & Blood Institute. One study, which has not yet begun recruitment, will seek to determine the antiarrhythmic effects of dietary n-3 fatty acids in patients with implanted defibrillators. The other, a Phase II/III trial, will investigate dietary n-3 fatty acids for the prevention of thrombotic pain episodes in sickle cell anemia. Overall, the trial is expected to last five years. A Phase I/II multicenter study being sponsored by the National Cancer Institute is looking at orally administered omega-3 fatty acids' efficacy in treating patients with advanced cancer and significant weight loss. Goals of the study are to "determine whether omega-3 fatty acids will reverse weight loss in advanced cancer patients...determine the maximum tolerated dose of omega-3 fatty acids in these patients...[and] determine whether omega-3 fatty acids will result in an antitumor response." The study expects to enroll between 57 and 63 patients. |